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RTF Template

Directorate General For Food And Veterinary

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	256/ADG//MV/OL/2023 DGAV
2. Name of Authorisation Holder	:	Sopro Distribuicao Farmaceutica Lda. (ORG-100040381 / LOC-100079496)
3. Address(es) of Site(s)	:	Rua Senhor Dos Aparecidos 867, Esmeriz, 4760-480, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Senhor Dos Aparecidos 867, Esmeriz, 4760-480
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-05-17
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Sopro Distribuicao Farmaceutica Lda.

(ORG-100040381 / LOC-100079496)

, Rua Senhor Dos Aparecidos 867, Esmeriz, 4760-480, Portugal

Veterinary medicinal products

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

Any restrictions or clarifying remarks (for all users): VMP Cold Chain 2/8ºC
VMP Cold Chain 8/15ºC
VMP Room temperature
VMP Immunological

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	256/ADG//MV/OL/2023 DGAV
	Page 1

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